Benchmark BMK6F105MRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00814548014043), received between Nov 4, 2015 and May 2, 2025 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO RETRACT THE 5F SELECT AND DECIDED TO REMOVE IT WITH THE BENCHMARK. UPON REMOVAL OF THE 5F SELECT AND BENCHMARK, IT WAS NOTED THAT THE BENCHMARK HAD FRACTURED. THE PHYSICIAN THEN USED A SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FRACTURED SEGMENT OF THE BENCHMARK FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NEURON SELECT CATHETER 6F (6F SELECT). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953806 ↗
• MalfunctionAug 5, 2024Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), AND A SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK INTO THE LEFT INTERNAL CAROTID ARTERY (ICA) VIA RADIAL ACCESS USING THE 5F SELECT AND SHEATH. WHILE REMOVING THE 5F SELECT, THE BENCHMARK STARTED TO LEAK NEAR THE HUB. THEREFORE, PHYSICIAN REMOVED THE BENCHMARK IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907866 ↗
• MalfunctionMar 25, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK TOWARD THE TARGET LOCATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE BENCHMARK WAS FRACTURED AT THE PROXIMAL END. THEREFORE, THE BENCHMARK REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976010 ↗
• MalfunctionDec 30, 2023Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK INTO THE CAROTID ARTERY USING THE SHEATH. WHILE ASPIRATING BLOOD FROM THE BENCHMARK USING A SYRINGE PRIOR TO PERFORMING AN ANGIOGRAPHY, THE PHYSICIAN NOTICED AIR LEAKING AT THE PROXIMAL END OF THE BENCHMARK. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422770 ↗
• MalfunctionOct 16, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE BENCHMARK OVER THE CATHETER AND GUIDEWIRE. THE PHYSICIAN FOUND THAT THE BENCHMARK WAS FRACTURED AT THE MID-SHAFT AND THEREFORE, THE BENCHMARK WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940954 ↗
• InjuryJun 1, 2022Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SHORT SHEATH AND A NON-PENUMBRA FLOW DIVERTING STENT. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE FLOW DIVERTING STENT USING THE BENCHMARK AND SHORT SHEATH. SUBSEQUENTLY, IT WAS NOTICED THAT THE STRAIN RELIEF OF THE BENCHMARK WAS LEAKING, AND AN AIR EMBOLISM WAS NOTED. THEREFORE, THE BENCHMARK WAS REMOVED. THE PHYSICIAN THEN TREATED THE AIR EMBOLISM BY PARTIALLY ASPIRATING USING A NON-PENUMBRA CATHETER AND THE REMAINDER BY A DOSE OF 100% OXYGEN. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 SYMPTOM FREE.

  Patient problems: Air Embolism

  MAUDE report 14569843 ↗
• MalfunctionJan 19, 2022Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A GUIDEWIRE, AND A 6F NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK OVER THE GUIDEWIRE AND THROUGH THE SHEATH, THE DISTAL PORTION OF THE BENCHMARK BROKE OFF. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN PART OF THE BENCHMARK. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287591 ↗
• MalfunctionJul 18, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BASILAR ARTERY (BA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK INTO THE PATIENT VIA DIRECT STICK. HOWEVER, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE BENCHMARK HAD MULTIPLE KINKS. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186818 ↗
• MalfunctionJun 25, 2021Material Puncture/Hole; Difficult to Advance; Physical Resistance/Sticking; Material Puncture/Hole; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RADIAL AND SUBCLAVIAN ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A BENCHMARK THROUGH A PROBABLE VASOSPASM OF THE RADIAL ARTERY. SUBSEQUENTLY, IT WAS NOTICED THAT THE BENCHMARK WAS PUNCTURED AND LEAKING AT THE PROXIMAL ONE THIRD. THE PROCEDURE WAS COMPLETED USING THE SAME BENCHMARK DUE TO THE APPROACH OF THE INTERVENTION BEING COMPLEX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072094 ↗
• MalfunctionMay 4, 2021Fracture; Leak/Splash; Fracture; Leak/Splash

  THE PATIENT WAS UNDERGOING A STENT-ASSISTED COILING PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA SHORT INTRODUCER SHEATH. IT WAS NOTED THAT PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A BENCHMARK THROUGH A SHORT INTRODUCER SHEATH INTO THE CERVICAL ARTERY. AFTERWARDS, AN ANGIOGRAM WAS PERFORMED AND SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE IMAGE WAS NOT CLEAR AND INDICATED POSSIBLE LEAKAGE SOMEWHERE ON THE BENCHMARK. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE BENCHMARK AND THE SHORT INTRODUCER SHEATH TOGETHER. UPON REMOVAL, IT WAS NOTICED THAT THE MID-SHAFT OF THE BENCHMARK WAS BROKEN BUT INTACT. IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE BENCHMARK FROM THE SHORT INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED BY PLACING A STENT IN THE VESSEL WITHOUT ANY INTERMEDIATE CATHETER AND A NEW INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770627 ↗
• MalfunctionApr 13, 2021Break; Leak/Splash; Break; Leak/Splash

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATION ARTERY (PCOM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A BENCHMARK INTO THE PATIENT AND THEN ADVANCED A MICROCATHETER INTO THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE BENCHMARK WAS LEAKING. UPON REMOVAL OF THE BENCHMARK, IT WAS NOTICED THAT THE PROXIMAL END OF THE BENCHMARK WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657451 ↗
• MalfunctionJan 15, 2021Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A BUBBLE IN THE ROTATING HEMOSTASIS VALVE (RHV) AND FOUND THAT THE PROXIMAL PORTION OF THE BENCHMARK WAS BENT AND WAS LEAKING FROM THE LOCATION OF THE BEND. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11178444 ↗
• MalfunctionNov 26, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE BENCHMARK BECAME KINKED AT THE PROXIMAL END WHILE ATTEMPTING TO ACCESS THE ANEURYSM. THEREFORE, THE BENCHMARK WAS REMOVED. THE PHYSICIAN ATTEMPTED TO CONTINUE THE PROCEDURE USING A NON-PENUMBRA CATHETER BUT WAS UNSUCCESSFUL. THEREFORE, THE PROCEDURE WAS ENDED, AND THE PATIENT WAS NOT TREATED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10907912 ↗
• MalfunctionJun 19, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK, IT KINKED; THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10175751 ↗
• MalfunctionJul 26, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, AFTER ADVANCING THE BENCHMARK INTO THE TARGET VESSEL USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN INJECTED CONTRAST AND NOTICED A LOSS OF CONTINUITY OF THE SHAFT OF THE BENCHMARK. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE BENCHMARK AND THE DISTAL END BROKE INTO TWO PIECES IN THE PHYSICIAN'S HANDS OUTSIDE OF THE PATIENT WITHOUT EXERCISING FORCE. THE PROCEDURE WAS THEN COMPLETED USING A NEW BENCHMARK AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833296 ↗
• MalfunctionJun 7, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS KINKED APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL TIP UPON REMOVAL FROM THE PACKAGING. THE DAMAGED BENCHMARK WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680151 ↗
• MalfunctionApr 12, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING BENCHMARK DELIVERY CATHETERS (BENCHMARKS). DURING THE PROCEDURE, THE DISTAL END OF A BENCHMARK BECAME KINKED WHILE BEING ADVANCED INTO A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND, THEREFORE, THE BENCHMARK WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW BENCHMARK INTO THE NEURON MAX, HOWEVER THE DISTAL END OF THE BENCHMARK FRACTURED WHILE BEING ADVANCED INTO THE NEURON MAX. THE PHYSICIAN THEN SUCCESSFULLY COMPLETED THE PROCEDURE USING A THIRD BENCHMARK WITH THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510264 ↗
• MalfunctionFeb 22, 2019Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE BENCHMARK IN THE NON-PENUMBRA SHORT SHEATH AND, CONSEQUENTLY THE PROXIMAL END OF THE BENCHMARK BROKE. THE BENCHMARK WAS, THEREFORE, REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WITH THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362750 ↗
• MalfunctionJan 14, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN FOUND THAT THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) HAD BECOME KINKED NEAR THE HUB. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 8245860 ↗
• MalfunctionJan 11, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING PREPARATION OF THE BENCHMARK ON THE BACK TABLE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE BENCHMARK THROUGH THE PEEL AWAY SHEATH INCLUDED IN THE BENCHMARK PACKAGING; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242227 ↗
• MalfunctionOct 29, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A HOSPITAL STAFF FOUND THAT A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS KINKED AFTER UNPACKING. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8017365 ↗
• MalfunctionOct 2, 2018Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS FRACTURED UPON OPENING THE PACKAGING. THE BROKEN BENCHMARK WAS FOUND PRIOR TO USE AND PRIOR TO THE PATIENT BEING ON THE TABLE. THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX 6F 088 LONG SHEATH (NEURON MAX).

  Patient problems: No Patient Involvement

  MAUDE report 7928774 ↗
• MalfunctionMay 7, 2018Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD A BENCHMARK INTO THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE IT. THE PHYSICIAN ALSO EXPERIENCED RESISTANCE WHILE REMOVING THE BENCHMARK AND UPON PULLING HARDER TO REMOVE THE BENCHMARK, THE PHYSICIAN NOTICED A KINK ON THE BENCHMARK. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491256 ↗
• MalfunctionMay 3, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIP OF A BENCHMARK DELIVERY CATHETER (BENCHMARK) HAD BECOME OVALIZED WHILE ATTEMPTING TO ADVANCE INTO THE INTRODUCER SHEATH. THE DAMAGE TO THE BENCHMARK OCCURRED PRIOR TO USE, AND, THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7485146 ↗
• MalfunctionApr 5, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS KINKED UPON REMOVAL FROM THE PACKAGING AT THE BACK TABLE. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE. THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7399707 ↗